Pronova Biopharma Norge v. Teva Pharma. USA, Inc.

Shipping samples that are covered by the patent-in-suit without a confidentiality agreement, without a limitation on usage, and to a skilled artisan that is able to ascertain the claimed elements, is a public use under § 102(b).

Fall 2013

GENERICally Speaking

Case Name: Pronova Biopharma Norge v. Teva Pharma. USA, Inc., Civ. Nos. 2012-1498, 2012-1499, 2013 U.S. App. LEXIS 18905 (Fed. Cir. Sept. 12, 2013) (Circuit Judges Dyk, O’Malley, and Wallach presiding; Opinion by O’Malley) (Appeal from D. Del., Robinson, J.)

Drug Product and Patent(s)-in-Suit: Lovaza® (omega-3-acid ethyl esthers); U.S. Pat. Nos. 5,656,667 (“the ’667 patent”) and 5,502,077 (“the ’077 patent”)

Nature of the Case and Issue(s) Presented: The issue presented was whether the invention claimed in ’667 patent was made publicly accessible by the predecessor company of Pronova more than one year prior to the filing of the ’667 patent application. Specifically, the court was presented with the discrete question of whether a use other than the intended use claimed in the patent-in-suit (treatment of hypertriglyceridemia) constituted an invalidating public use under § 102(b).

The district court held a bench trial and found that Teva’s ANDA product infringed all of the asserted claims of the ’077 and ’667 patents, and that both patents were valid and enforceable. Teva appealed. The Federal Circuit reversed and remanded the case to the district court with instructions to enter judgment in favor of Teva.

Why Teva Prevailed: All the parties agreed that the allegedly invalidating use of the claimed compound involved versions of the drug that were “ready for patenting,”  meaning that the invention had clearly been reduced to practice at the time the alleged public or commercial use had taken place.

The public use alleged by Teva occurred on September 8, 1987, more than one year before the ’667 patent application was filed. Norsk Hydro, the predecessor company to Pronova, sent Dr. Victor Skrinska of St. Vincent Charity Hospital liquid vials of K-80 ethyl ester composition. By Pronova’s admission, the samples that were shipped to Dr. Skrinska met all asserted claims of the ’667 patent. The samples were sent to Dr. Skrinska in the absence of any type of confidentiality agreement. Moreover, Dr. Skrinska testified that he in fact shared information regarding the samples with other members of the medical community and did not treat the information as confidential.  The court also found that the samples were provided to Dr. Skrinska without any limitations as to the manner in which they were to be used. Indeed, Pronova did not even know what Dr. Skrinska did with the samples after he received them. The samples were shipped to Dr. Skrinska with a certificate of analysis disclosing that the sample met each limitation of the ’667 patent with respect to relative concentrations of each of the fish oil compounds. Dr. Skrinska later performed his own analytical tests confirming the concentrations. Lastly, the court gave weight to the fact that the shipment of samples was sent to someone who was highly skilled in the art, and was readily able to ascertain each of the elements of the claimed invention.

The court rejected Pronova’s argument that in order for a public use to occur the compound needed to be used in the manner claimed in the patent. Rather, it concluded that when a compound is provided without restriction to one highly skilled in the art, that compound’s formulation is disclosed in detail and the formulation is subject to confirmatory testing, no other activity is needed to render that use an invalidating one.

The court declined to consider other arguments made by the parties regarding the invalidity of the ’667 patent, finding the § 102(b) issue to be dispositive. The court also declined to consider arguments related to the ’077 patent because it expired prior to oral argument in the case.

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